Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry

摘要

This guidance finalizes the draft guidance of the same title, dated July 2005. This guidance also supersedes the recommendations for reentry of donors deferred because of anti-HIV-1 test results, HIV-1 p24 antigen test results, and anti-HCV test results that were provided in the FDA memoranda entitled, Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products, April 23, 1992; Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV), August 5, 1993; Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen, August 8, 1995.